Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Special Report on Antibody-Drug Conjugates: Technical Challenges and Opportunities

Among the emerging targeted therapies in biotechnology, antibody–drug conjugates (ADCs) hold a unique position. An ADC consists of a monoclonal antibody (MAb) with affinity to tumor cells, a cytotoxic small-molecule payload, and a linker connecting the two. Together the MAb, conjugation chemistry, and cytotoxin increase the complexity of ADCs several-fold relative to unmodified MAbs — and exponentially relative to chemotherapies.

Viewing ADCs as hybrids of antibody- and chemotherapy-based cancer therapies is tempting. That description applies chemically and structurally, but ADCs’ differences from conventional therapies are striking, as is there underlying rationale. Tiffani A. Manolis (pharma segment manager at Agilent Technologies in Santa Clara, CA) likens ADCs to biosimilars in this way: Developers of the latter use innovator MAbs as comparator molecules, whereas ADCs apply them as delivery vehicles. Same molecule, different strategy — and both rely heavily on analytics for characterization.

ADCs use their antibody components to home in on tumor cells bearing specific markers or receptors. Once bound to those cells, ADC and receptor internalize together, and the small-molecule component releases to kill them. The development pipeline includes several variations on this theme.

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